BEUDAMED
    FDA Registration Active 🇨🇳 China

    INNOVEX MEDICAL CO., LTD.

    Reg #: 3032859397 · FEI: 3032859397 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    INNOVEX MEDICAL CO., LTD.
    Registration Number
    3032859397
    FEI Number
    3032859397
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China, 1st, 2nd Floor, No.14 Building and 3rd, 4th Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243820

    Owner / Operator

    Firm Name
    INNOVEX MEDICAL CO., LTD.
    Operator Number
    10092290
    Address
    2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201201
    Country
    CN
    Correspondent
    Alice Wang

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Dislodger, Stone, Flexible FGO
    Bottle, Collection, Vacuum KDQ
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Single Use Grasping Forceps(IVX-GF1-1806A, IVX-GF1-1808A, IVX-GF1-1810A, IVX-GF1-1812A) Urological Stone Extraction Baskets(IVX-US-T0810, IVX-US-T0810S, IVX-US-T1110, IVX-US-T1110S) Urological Stone Extraction Baskets(IVX-US-F1110, IVX-US-F1110S, IVX-US-F1110L); Urological Sampler Sets (IVX-NB-150) Hoover Negative Pressure Access Sheath(IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device